UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020768 |
|---|---|
| Receipt number | R000023968 |
| Scientific Title | Exploratory study of fluorescence ICG sentinel lymph node biopsy using medical imaging projection system in patients with breast cancer |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2016/01/27 21:22:37 |
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Basic information
Public title
Exploratory study of fluorescence ICG sentinel lymph node biopsy using medical imaging projection system in patients with breast cancer
Acronym
Exploratory study of fluorescence ICG sentinel lymph node biopsy using medical imaging projection system in patients with breast cancer
Scientific Title
Exploratory study of fluorescence ICG sentinel lymph node biopsy using medical imaging projection system in patients with breast cancer
Scientific Title:Acronym
Exploratory study of fluorescence ICG sentinel lymph node biopsy using medical imaging projection system in patients with breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical usefulness of fluorescence ICG sentinel lymph node biopsy using medical imaging projection system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification rate of sentinel lymph node using medical imaging projection system
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Identification of sentinel lymph node using medical imaging projection system
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically diagnosed female breast cancer patients
2) Clinical node negative (cN0)
3) Sentinel lymph node biopsy is planned for primary breast cancer
4) Age between 20 to 75
5) Informed consent
Key exclusion criteria
1) After excisional biopsy for breast cancer or surgery for axillary lymph node
2) One who is allergic to ICG or iodine
3) Pregnant women or lactating women
4) Not suitable for this study judged by the investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Takada |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
Address
54 Kawaracho, Shogoin. Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
masahiro@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Takada |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
Address
54 Kawaracho, Shogoin. Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
masahiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Panasonic Corporation
Yamada Shadowless Lamp Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 27 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023968
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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